The challenge of PERSISTENT FACIAL ERYTHEMA (PFE) is

More than Face value

There’s what patients see and what you should target

Actual PFE patient

Explore the benefits

The challenge of PERSISTENT FACIAL ERYTHEMA (PFE) is

More than Face value

There’s what patients see and what you should target

Actual PFE patient

Explore the benefits

Chronic vascular dysregulation CAUSES PFE1,2

PFE in rosacea—which does not respond to treatments for papules and pustules—is primarily caused by chronic vascular dysregulation. Vasodilation increases cutaneous blood flow at affected sites, leading to facial erythema that may become permanent over time if left untreated.3

Targeted Mechanism of action4

RHOFADE is the first and only alpha1A-adrenoceptor agonist approved to treat PFE in rosacea, causing constriction of smooth muscle in blood vessel walls to help prevent progression and reduce PFE. RHOFADE provides an opportunity to address chronic vascular dysregulation and target PFE at the source.2,4

PFE reduction in as little as 1 hour5

RHOFADE delivers rapid reductions in redness of PFE, with visible improvement seen in as little as 1 hour on the first day of treatment.* Through 52 weeks of treatment, RHOFADE provided continual reductions in redness—with nearly half of patients seeing a ≥1-grade improvement at week 52 before daily application.5-8,†

CONSISTENT safety profile6

RHOFADE cream offers consistent tolerability with a low incidence of adverse events. Once-daily RHOFADE for 52 weeks resulted in fewer adverse events and a high degree of dermal tolerability.6

CEA: Clinician Erythema Assessment; PFE: persistent facial erythema; SSA: Subject Self-Assessment.

The REVEAL Trial: The primary efficacy endpoint was defined as the proportion of patients with a ≥2-grade reduction in erythema from baseline on both the CEA and SSA scales measured at hours 3, 6, 9, and 12 on day 29.4

A RHOFADE response was defined as a composite ≥1-grade improvement in erythema on the CEA and SSA scales at any time point after the dose on day 1 or at any time point during a study visit at weeks 4, 26, or 52.8

Important Safety Information

INDICATION: RHOFADE® (oxymetazoline HCl) Cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. ADVERSE EVENTS: In the pivotal trials, the most common adverse reactions (≥1%) were: application-site dermatitis (2%), pruritus, erythema and pain (all 1%), and worsening inflammatory lesions of rosacea (1%).

Please see Full Prescribing Information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Important Safety Information

INDICATION: RHOFADE® (oxymetazoline HCl) Cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. ADVERSE EVENTS: In the pivotal trials, the most common adverse reactions (≥1%) were: application-site dermatitis (2%), pruritus, erythema and pain (all 1%), and worsening inflammatory lesions of rosacea (1%).

Please see Full Prescribing Information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References

  1. Steinhoff M, Buddenkotte J, Aubert J, et al. Clinical, cellular, and molecular aspects in the pathophysiology of rosacea. J Investig Dermatol Symp Proc. 2011;15(1):2-11. doi:10.1038/jidsymp.2011.7
  2. Del Rosso JQ, Tanghetti E. Topical oxymetazoline hydrochloride cream 1% for the treatment of persistent facial erythema of rosacea in adults: a comprehensive review of current evidence. J Clin Aesthet Dermatol. 2021;14(3):32-37.
  3. Del Rosso JQ. Advances in understanding and managing rosacea: part 2: the central role, evaluation, and medical management of diffuse and persistent facial erythema of rosacea. J Clin Aesthet Dermatol. 2012;5(3):26-36.
  4. RHOFADE® Cream. Prescribing information. EPI Health, LLC; 2019.
  5. Eichenfield LF, Del Rosso JQ, Tan JKL, et al. Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1.0% for persistent erythema of rosacea in a phase IV study. Br J Dermatol. 2019;180(5):1050-1057. doi:10.1111/bjd.17462
  6. Draelos ZD, Gold MH, Weiss RA, et al. Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 52-week open label REVEAL trial. J Am Acad Dermatol. 2018;78(6):1156-1163. doi:10.1016/j.jaad.2018.01.027
  7. Kircik LH, DuBois J, Draelos ZD, et al. Pivotal trial of the efficacy and safety of oxymetazoline cream 1.0% for the treatment of persistent facial erythema associated with rosacea: findings from the first REVEAL trial. J Drugs Dermatol. 2018;17(1):97-105.
  8. Gold MH, Lebwohl M, Biesman BS, et al. Daily oxymetazoline cream demonstrates high and sustained efficacy in patients with persistent erythema of rosacea through 52 weeks of treatment. J Am Acad Dermatol. 2018;79(3):e57-e59. doi:10.1016/j.jaad.2018.05.037